Intelence is an antiviral medicine that prevents the human immunodeficiency virus (HIV) from multiplying in your body.

Intelence is used with other medicines to treat HIV in adults and children who are at least 6 years old. HIV causes the acquired immunodeficiency syndrome (AIDS).

Intelence is not a cure for HIV or AIDS.

In rare cases, Intelence can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.

Intelence must be taken in combination with other HIV medications. However, some drugs can raise or lower your blood levels of etravirine. Intelence can also affect blood levels of certain other drugs. This can make your medicines less effective or increase side effects. TELL YOUR DOCTOR ABOUT ALL OTHER MEDICINES YOU USE.

Before taking this medicine

You should not take Intelence if you are allergic to etravirine.

To make sure you can safely take Intelence, tell your doctor if you have any liver disease, including hepatitis B or C.

Intelence must be taken in combination with other HIV medications. However, there are certain combinations of medicines that should not be used together with etravirine. Follow your doctor's dosing instructions very carefully.

You SHOULD NOT take Intelence together with:

• delavirdine;

• efavirenz;

• nevirapine;

• rifabutin, rifapentine, rifampin;

• rilpivirine;

• St. John's wort;

• ritonavir when given with fosamprenavir or tipranavir;

• ritonavir in doses of more than 600 milligrams twice daily; or

• seizure medications - carbamazepine, phenytoin, phenobarbital.

You MUST take Intelence together with ritonavir if you are also taking a protease inhibitor, such as atazanavir, dolutegravir, fosamprenavir, indinavir, or nelfinavir.

Tell your doctor if you are pregnant or plan to become pregnant during treatment. HIV can be passed to your baby if you are not properly treated during pregnancy. Take all of your HIV medicines as directed to control your infection.

Women with HIV or AIDS should not breast-feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

Take Intelence exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended. Intelence must be taken in combination with other HIV medications. Follow your doctor's dosing instructions very carefully.

If a child is taking this medication, tell your doctor if the child has any changes in weight. Intelence doses are based on weight in children.

Intelence works best if you take it after a meal. Do not take it on an empty stomach.

Do not crush, chew, or break a tablet. Swallow it whole with liquid such as water.

If you cannot swallow an Intelence tablet whole, place it into a glass of water and allow the tablet to disperse in the liquid. The tablet will not dissolve completely. Drink this mixture right away. To make sure you get the entire dose, add a little more liquid to the same glass, swirl gently and drink right away.

While using Intelence, you may need frequent blood tests at your doctor's office.

Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice. Every person with HIV or AIDS should remain under the care of a doctor.

Store at room temperature away from moisture and heat. Keep the tablets in their original container.

Usual Adult Dose for HIV Infection:

200 mg orally twice a day after a meal

Usual Pediatric Dose for HIV Infection:

6 to less than 18 years:
16 kg to less than 20 kg: 100 mg orally twice a day after a meal
20 kg to less than 25 kg: 125 mg orally twice a day after a meal
25 kg to less than 30 kg: 150 mg orally twice a day after a meal
30 kg or more: 200 mg orally twice a day after a meal

You should not take Intelence if you are allergic to etravirine.

To make sure you can safely take Intelence, tell your doctor if you have any liver disease, including hepatitis B or C.

Intelence must be taken in combination with other HIV medications. However, there are certain combinations of medicines that should not be used together with etravirine. Follow your doctor's dosing instructions very carefully.

You SHOULD NOT take Intelence together with:

• delavirdine;

• efavirenz;

• nevirapine;

• rifabutin, rifapentine, rifampin;

• rilpivirine;

• St. John's wort;

• ritonavir when given with fosamprenavir or tipranavir;

• ritonavir in doses of more than 600 milligrams twice daily; or

• seizure medications - carbamazepine, phenytoin, phenobarbital.

You MUST take Intelence together with ritonavir if you are also taking a protease inhibitor, such as atazanavir, dolutegravir, fosamprenavir, indinavir, or nelfinavir.

Tell your doctor if you are pregnant or plan to become pregnant during treatment. HIV can be passed to your baby if you are not properly treated during pregnancy. Take all of your HIV medicines as directed to control your infection.

Women with HIV or AIDS should not breast-feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

If you are less than 6 hours late in taking your medicine, take the missed dose after your next meal. Then return to your regular dosing schedule. Do not take extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Taking this medication will not prevent you from passing HIV to other people. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Get emergency medical help if you have any of these signs of an allergic reaction to Intelence: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

In rare cases, Intelence can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.

Stop using Intelence and call your doctor at once if you have:

• swelling, rapid weight gain, little or no urinating;

• confusion, seizure;

• liver problems: nausea, upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• the first sign of any type of skin rash, no matter how mild; or

• severe skin reaction - fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Intelence may increase your risk of certain infections or autoimmune disorders by changing the way your immune system works. Symptoms may occur weeks or months after you start treatment with this medicine. Tell your doctor if you have:

• signs of a new infection - fever, night sweats, swollen glands, mouth sores, diarrhea, stomach pain, weight loss;

• chest pain (especially when you breathe), dry cough, wheezing, feeling short of breath;

• cold sores, sores on your genital or anal area;

• rapid heart rate, feeling anxious or irritable, weakness or prickly feeling, problems with balance or eye movement;

• trouble speaking or swallowing, severe lower back pain, loss of bladder or bowel control; or

• swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence, loss of interest in sex.

Common Intelence side effects may include:

• diarrhea;

• numbness or tingly feeling in your hands or feet;

• rash; or

• changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Some drugs can raise or lower your blood levels of Intelence, which may cause side effects or make etravirine less effective. This medicine can also affect blood levels of certain other drugs, making them less effective or increasing side effects.

Many drugs can interact with etravirine. Not all possible interactions are listed here. TELL YOUR DOCTOR ABOUT ALL OTHER MEDICINES YOU USE, and any you start or stop using during treatment with Intelence, especially:

• artemether and lumefantrine;

• boceprevir or telaprevir;

• clarithromycin;

• clopidogrel;

• dexamethasone;

• diazepam (Valium);

• maraviroc;

• an antifungal medicine - itraconazole, ketoconazole, posaconazole;

• a blood thinner - warfarin, Coumadin;

• cholesterol lowering medicine - atorvastatin, fluvastatin, lovastatin, pitavastatin, simvastatin;

• heart rhythm medicine - amiodarone, digoxin, disopyramide, flecainide, mexiletine, propafenone, quinidine;

• medicine for erectile dysfunction or pulmonary arterial hypertension - sildenafil, tadalafil, vardenafil;

• medicines to prevent organ transplant rejection - cyclosporine, sirolimus, tacrolimus; or

• narcotic medication - buprenorphine, methadone.

This list is not complete. Other drugs may interact with etravirine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.